An interventional study of Laparoscopy endoscopy cooperated surgery and Dan Vinchi robot endoscopy cooperated surgery in Gastric Submucosal Tumors, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
Gastric submucosal tumors (SMTs) are rare findings during routine upper endoscopy; the incidence of these lesions may be as high as 0.4%.SMTs display a wide spectrum,ranging from benign to highly malignant, with gastrointestinal stromal tumors (GISTs) being the most common type.SMTs is a gastrointestinal tumor,surgical operation is still the main method of gastric tumor treatment.The common surgical methods for resection of SMTs include laparotomy and laparoscopic surgery.In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect.In recent years, some scholars have put forward the concept of the third space.The concept of the "third space" was initiatively proposed at the same time when new endoscopic surgery approach via natural orifice transluminal was put forward(NOTES). To be specific, with respect to the first space(lumen) and second space(peritoneal cavity),the third space refers to the intramural space.The aim of the study is to compare value (outcomes/costs) of surgery in patients with SMTs by 2 approaches:Laparoscopic and Endoscopic cooperative surgery(LECS),Robotic and Endoscopic cooperative surgery(RECS).First of all, the investigators will collect 80 cases of SMTs patients, randomly assigned for the LECS and RECS groups. Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency,complications and other indicators.
First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic and Endoscopic cooperative surgery,LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .
Procedure: Laparoscopy endoscopy cooperated surgery
Robotic and Endoscopic cooperative surgery,RECS resects the tumor completely by Dan Vinchi robot with the help of the precise positioning and guidance of endoscopy .
Procedure: Dan Vinchi robot endoscopy cooperated surgery
LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy
RECS resects the tumor completely by Dan Vinchi Robot with the help of the precise positioning and guidance of endoscopy
operation time
record in minutes,from the beginning of anesthesia to the end
Time frame: 1 hours to 6 hours through the surgery completion
blood loss
from the surgical record sheet
Time frame: 1 hours to 6 hours through the surgery completion
success rate
to ensure the integrity of the tumor and obtain the negative surgical margin
Time frame: from two days to two weeks after surgery
time in bed
the time in bed to the postoperative patient
Time frame: from two days to two weeks after surgery
time to take food
the time to eat to the postoperative patient
Time frame: from two days to two weeks after surgery
postoperative complication rate
including anastomotic stoma fistula,anastomotic stenosis,abdominal infection,postoperative bleeding
Time frame: from two weeks to one year after surgery
tumor recurrence rate
periodic review the CT or MRI or endoscope
Time frame: from one month to 2 years after surgery
hospitalization expenses
total hospitalization expenses
Time frame: 1 month
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University